Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYLEGACY DRIVER; HEX TOOL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYLEGACY DRIVER; HEX TOOL Back to Search Results
Catalog Number HT2.5SG
Medical Device Problem Codes Separation Failure (2547); Material Deformation (2976)
Health Effect - Clinical Codes Failure of Implant (1924); No Information (3190)
Date of Event 02/13/2019
Type of Reportable Event Malfunction
Event or Problem Description
Per complaint (b)(4), a driver could not be removed from the dental implant transfer during initial placement.The implant was removed and replaced with a new one within the same visit.No adverse patient consequences were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SIMPLYLEGACY DRIVER
Common Device Name
HEX TOOL
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8425228
Report Number3001617766-2019-00088
Device Sequence Number1785705
Product Code NDP
UDI-Device Identifier10841307119869
UDI-Public10841307119869
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/03/2022
Device Catalogue NumberHT2.5SG
Device Lot Number101289
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/15/2019
Initial Report FDA Received Date03/15/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age41 YR
-
-